Effects of Remifentanil on Breathing Pattern, Respiratory Effort and Gas Exchange in Mechanically Ventilated Patients.
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- respiratory rate/tidal volume
研究概览
简要总结
Sedation is widely used in mechanically ventilated patients. Propofol, benzodiazepines and opioids are the most used drugs. The study hypothesis is that sedation with remifentanil (an opioid drug) could improved respiratory pattern and effort in mechanically ventilated patients with rapid shallow breathing or high respiratory rate.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •pressure support ventilation or CPAP
- •respiratory rate > 35.min-1
- •respiratory rate/tidal volume > 105
排除标准
- •vasoactive agents (dopamine lower than 5 mcg.kg-1.min-1 is not considered as vasoactive agent)
- •body temperature > 38 °C
- •Glasgow Coma Scale < 9
- •FIO2 > 0.6
- •PEEP > 10 cmH2O
- •pH < 7.30
研究组 & 干预措施
treatment
Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions.
干预措施: remifentanil (Drug)
treatment
Any patient alternatively receive both remifentanil and isotonic saline (placebo)infusion. The order of infusion is randomized. An interval of 30 minutes is planned between the two infusions.
干预措施: placebo (Drug)
结局指标
主要结局
respiratory rate/tidal volume
时间窗: before and after remifentanil infusion; before and after placebo infusion.
pressure-time product
时间窗: before and after remifentanil infusion; before and after placebo infusion.
次要结局
- double product of respiratory system(before and after remifentanil infusion; before and after placebo infusion.)
- dynamic intrinsic PEEP(before and after remifentanil infusion; before and after placebo infusion.)
- adverse events(during all the study period)
- arterial pH(before and after remifentanil infusion; before and after placebo infusion.)
- level of sedation (RASS)(before and after remifentanil infusion; before and after placebo infusion.)